País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
RISEDRONATE SODIUM CALCIUM CARBONATE COLECALCIFEROL
IPS Healthcare Limited
RISEDRONATE SODIUM CALCIUM CARBONATE COLECALCIFEROL
35 + 1000 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Withdrawn
2013-12-02
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Actonel Plus Ca & D 35mg film-coated tablets + 1000mg/880 IU Effervescent Granules. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 35 mg risedronate sodium, (equivalent to 32.5 mg risedronic acid). Each sachet of effervescent granules contains 2500 mg calcium carbonate equivalent to 1000 mg calcium and 22 micrograms (880 IU) colecalciferol (vitamin D 3 ). Excipients: Each film-coated tablet contains lactose. Each sachet of effervescent granules contains potassium (163 mg), sucrose, soya-bean oil and sorbitol. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablets. _Product imported from the UK:_ Risedronate tablets: Oval, light-orange, film-coated tablets with RSN on one side and 35mg on the other. Effervescent granules: Calcium carbonate/colecalciferol, white effervescent granules. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures (see section 5.1). Actonel Plus Ca & D is only intended for use in assessed patients for whom the amount of calcium and vitamin D 3 included is considered to provide adequate supplementation. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION A weekly unit of Actonel Plus Ca & D consists of 1 Actonel 35 mg film-coated tablet and 6 calcium/vitamin D 3 sachets in a box. The recommended dose in adults is 1 Actonel 35 mg tablet on the first day followed on the next day by 1 calcium/vitamin D 3 sachet daily for 6 days. This 7-day sequence is then repeated each week starting with Actonel 35 mg tablet. Actonel 35 mg (light-orange tablet): The Actonel 35 mg tablet Leia o documento completo